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10.1016/j.jviromet.2021.114178

http://scihub22266oqcxt.onion/10.1016/j.jviromet.2021.114178
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33961910!8095018!33961910
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suck abstract from ncbi


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pmid33961910      J+Virol+Methods 2021 ; 294 (ä): 114178
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  • Performance evaluation of the Simtomax(R) CoronaCheck rapid diagnostic test #MMPMID33961910
  • Ducrest PJ; Freymond A; Segura JM
  • J Virol Methods 2021[Aug]; 294 (ä): 114178 PMID33961910show ga
  • The aim of this study was to evaluate the diagnostic performance of Simtomax(R) CoronaCheck, a serology rapid diagnostic test (RDT) for the detection of IgG and IgM against SARS-CoV-2. 48 plasma samples positive for SARS-CoV-2 based on RT-PCR and 98 negative control samples were studied. Diagnostic performance of the IgG/IgM RDT was assessed against RT-PCR and the electro-chemiluminescence immunoassay (ECLIA) Elecsys(R) Anti-SARS-CoV-2 total Ig. Overall, the RDT sensitivity was 92 % (95 % confidence interval [95 %CI]: 79-97), specificity 97 % (95 % CI: 91-99 %), PPV 94 % (95 % CI: 81-98) and the NPV 96 % (95 % CI: 89-99). When considering only samples collected >/= 15 days post-symptoms (DPS), the sensitivity increased to 98 % (95 %CI: 86-100) and the specificity was 97 % (95 % CI: 91-99 %). Two samples with 180 DPS were still positive for IgG. Globally, this IgG/IgM RDT displayed a high diagnostic accuracy for SARS-CoV-2 IgG/IgM detection in plasma samples in high COVID-19 prevalence settings. It could be effectively used, in absence of facilities for routine diagnostic serology, for samples with a DPS between 15 and 180 days.
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |COVID-19 Serological Testing/methods/*standards[MESH]
  • |COVID-19/*diagnosis/immunology[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Immunoassay/methods/*standards[MESH]
  • |Immunoglobulin G/blood[MESH]
  • |Immunoglobulin M/blood[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Reagent Kits, Diagnostic/*standards[MESH]
  • |SARS-CoV-2/immunology[MESH]
  • |Sensitivity and Specificity[MESH]


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